Many types of drugs are taken over a variety of days in varying amounts in order to provide for their effective administration. Packages have been developed for aiding the user of such drugs to comply with proper administration of those drugs over a period of days. Typical of such drugs are birth control pills which are taken over a period of days corresponding to a woman's menstrual cycle and the administration of anti-inflammatory drugs such as cortisone and cortisone-like drugs for the treatment of various ailments. None of the dispensing apparatus associated with such multiple day administered drugs is geared to administration of drugs on a calendar day basis; rather they are geared to the administration of drugs irrespective of the particular day of the month and indeed are typically administered so as to be timed to a body cycle.
The present invention is directed to the administration of the drugs in pill form whose administration is based upon the actual calendar date and thus are geared to initial administration on the first day of a given month. Thereafter, the patient continues to take the pill or pills on a daily basis, corresponding to the days of the month. If the patient fails to take the pill or pills for a given day, he or she merely takes the pill or pills for the following day leaving those for the previous day in the dispensing package. In this way, a complete verifiable record of patient compliance is available to the attending physician, thereby allowing the physician to be better able to determine what course of action to take depending upon the nature of this compliance.
The present invention is particularly suited for the administration of drugs for the treatment of menopausal symptoms. It is known that during the natural course of a woman's life she will experience a decrease in estrogen production normally between the ages of 45 and 55. Such decrease in estrogen production can also be caused by surgical removal of the ovaries. In either case, when the amount of estrogen in the blood begins to decrease, a woman may develop various systems including the feelings of warmth in the face, neck, chest, or sudden intense episodes of heat and sweating throughout the body (typically known as "hot flashes") with the severity of these symptoms varying from woman to woman. Some women also may develop atrophic vaginitis which can cause discomfort. In order to treat these symptoms, estrogens may be prescribed by the attending physician for a period of a few months or longer while the woman's body begins to adjust to her lower estrogen production levels.
It has also been discovered that a woman with lower estrogen production usually has a rapid loss of bone density with a resultant weakening of the structural integrity of the bones, thus increasing the risk of fracture. This general condition is known as osteoporosis; and, as reported in the Update of the Journal of the American College of Obstetricians and Gynecologists, Volume 7, Number 4, pages 2-3 (for year 1981) and Volume 8, Number 2, page 1 (for year 1982) it has been estimated that 25 percent of menopausal women will have fractures related to osteoporosis. Treatment for this problem is the administration of estrogen, progesterone and calcium to the patient, taken over the course of each calendar month. It has been recommended in these articles that post-menopausal women should take some form of calcium replacement, such as 1.5 grams per day of calcium carbonate, in order to replenish the calcium which is lost as a result of reduced estrogen and progesterone production.
The present invention presents a calendar-oriented prescriptive drug dispenser which can provide estrogen, progesterone, and calcium to a patient under the care of a gynecologist or other physician. In order to facilitate patient compliance, the present invention provides a dispenser in which the days of the month are associated with pill-containing enclosures having a one-to-one correspondence to each day of a calendar month. The patient is typically instructed to begin the medication on the first day of the next succeeding month and if a day is missed, to simply skip that pill-containing enclosure and continue with those for the remainder of the month. At the end of the month the physician, if he or she desires, can by examining the dispenser, ascertain the amount of patient compliance with the prescriptive drugs. It has been experimentally found that women who have used the dispenser according to the present invention have extremely high compliance with the prescriptive drug regimen, while those who are requested to take estrogen, progesterone, and calcium pills over the course of the month without this dispenser have relatively poor compliance with the regimen.
Thus the present invention provides the means for insuring high compliance with a calendar-oriented prescriptive drug regimen and also provides the means for determining this compliance by the attending physician.